FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 1, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenstr öm’s Macroglobulinemia
CAMBRIDGE, Mass.& BEIJING, September 01, 2021--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that Brukinsa... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 1, 2021 Category: Drugs & Pharmacology Source Type: news

UCB Announces Briviact (brivaracetam) Now FDA-Approved to Treat Partial-Onset Seizures in Pediatric Patients One Month of Age and Older
ATLANTA, Aug. 30, 2021 /PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 30, 2021 Category: Drugs & Pharmacology Source Type: news

Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma
Tibsovo is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma BOSTON, Aug. 25, 2021 /PRNewswire/ -- Servier Pharmaceuticals, a growing leader in oncology committed to bringing the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 25, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency
COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 25, 2021 Category: Drugs & Pharmacology Source Type: news

Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke Kit for the Treatment of Severe Hypoglycemia
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit– three different administration options to accommodate patients’ preferences Gvoke... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients
STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Korsuva (difelikefalin) for injection for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2 billion Pfizer-BioNTech doses have been... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 23, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Approves Opdivo (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma
PRINCETON, N.J.--(BUSINESS WIRE) August 20, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 20, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jardiance (empagliflozin) to Treat Adults Living with Heart Failure with Reduced Ejection Fraction
Ridgefield, Conn. and Indianapolis, August 18, 2021– Jardiance (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2021 Category: Drugs & Pharmacology Source Type: news

GSK Receives FDA Accelerated Approval for Jemperli (dostarlimab-gxly) for Adult Patients with Mismatch Repair-Deficient (dMMR) Recurrent or Advanced Solid Tumors
17 August 2021 Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% across dMMR solid tumors 95% of responders had a duration of response of≥6 months GlaxoSmithKline (GSK) plc... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for Use in Insulin Pumps
INDIANAPOLIS, Aug. 16, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company's (NYSE: LLY) rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) 100 units/mL indicated to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
KENILWORTH, N.J.--(BUSINESS WIRE) August 13, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Welireg, an oral hypoxia-inducible factor-2... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 13, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves TicoVac (tick-borne encephalitis vaccine) to Prevent Tick-Borne Encephalitis (TBE)
NEW YORK--(BUSINESS WIRE) August 13, 2021 -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TicoVac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 13, 2021 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults
DUBLIN, Aug. 12, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 12, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC)
August 11, 2021 Keytruda Plus Lenvima Is Now Approved for Two Types of Cancer, Including Advanced RCC Based on Phase 3 CLEAR/KEYNOTE-581 Trial, Keytruda Plus Lenvima Significantly Reduced Risk of Disease Progression or Death by 61% Versus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 11, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease
PARIS– August 6, 2021 - The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus
2 August 2021 -- AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.1 The approval by the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 2, 2021 Category: Drugs & Pharmacology Source Type: news

Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
TITUSVILLE, N.J.– July 30, 2021– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) injection for intravenous (IV) use for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 30, 2021 Category: Drugs & Pharmacology Source Type: news

GSK Announces FDA Approval for Nucala (mepolizumab) for use in Adults with Chronic Rhinosinusitis with Nasal Polyps
29 July 2021 -- GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 29, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
NORTH CHICAGO, Ill., July 29, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 29, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
SILVER SPRING, Md., July 28, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris
NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 27, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery
KENILWORTH, N.J.--(BUSINESS WIRE) July 27, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 27, 2021 Category: Drugs & Pharmacology Source Type: news

Shingrix Approved in the US for Prevention of Shingles in Immunocompromised Adults
Philadelphia, London -- 26 July 2021 -- GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 26, 2021 Category: Drugs & Pharmacology Source Type: news

Bydureon BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older
WILMINGTON, Del.--(BUSINESS WIRE) July 23, 2021--AstraZeneca’s Bydureon BCise (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 23, 2021 Category: Drugs & Pharmacology Source Type: news

Dalvance (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients
NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma
KENILWORTH& WOODCLIFF, N.J.--(BUSINESS WIRE) July 22, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 22, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)
BOSTON, July 20, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food& Drug Administration (FDA) approval of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Expands Indication for Prograf for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Octapharma ’s Octagam 10% for Adult Dermatomyositis
PARAMUS, N.J.--(BUSINESS WIRE) July 20, 2021 --The U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fexinidazole as the First All-Oral Treatment for Sleeping Sickness
July 19, 2021 -- The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults
KENILWORTH, N.J.--(BUSINESS WIRE)-- (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
NEW YORK, NY / ACCESSWIRE / July 16, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
WHIPPANY, N.J.-- July 9, 2021 (BUSINESS WIRE)-- Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Regular Approval and Expands Indication for Padcev (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer
Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial First and Only FDA-Approved Therapy for Urothelial Cancer Patients Who Are Cisplatin-Ineligible and Have Previously Received One or More Prior Therapies, Based on... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Indication for Merck ’s Keytruda (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)
Keytruda Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation KENILWORTH, N.J.--(BUSINESS WIRE) July 6, 2021 -- Merck (NYSE: MRK), known as MSD... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 6, 2021 Category: Drugs & Pharmacology Source Type: news

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis
BALTIMORE, July 1, 2021 /PRNewswire/ --Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
DUBLIN, June 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
DUBLIN, June 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis
EMERYVILLE, Calif.--(BUSINESS WIRE) June 24, 2021 --Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on eye care, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 24, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children
June 21, 2021 -- Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Soaanz (torsemide) for Edema Treatment in Patients with Heart Failure and Renal Disease
VIENNA, VA. (PRWEB) JUNE 21, 2021 Sarfez Pharmaceuticals announced today approval by the U.S. Food and Drug Administration (FDA) of the Virginia-based company’s New Drug Application for Soaanz, a once-a-day improved formulation of the loop... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use
WHIPPANY, N.J.--(BUSINESS WIRE) June 17, 2021-- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Astepro Allergy (Azelastine HCI .15%) as an over-the-counter (OTC) product for the temporary relief of nasal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 17, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Blueprint Medicines' Ayvakit (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis
First precision therapy that specifically targets the primary driver of the disease Durable clinical responses, including complete remissions, shown in patients with or without prior treatment Full approval supported by robust efficacy and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rezipres (ephedrine hydrochloride injection) for Hypotension During Anesthesia
DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres (ephedrine hydrochloride injection) for the treatment of clinically... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 15, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 10, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 10, 2021 Category: Drugs & Pharmacology Source Type: news

Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
BOSTON--(BUSINESS WIRE)--Jun. 9, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 9, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older
First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 8, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer ’s Disease
CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2021 Category: Drugs & Pharmacology Source Type: news